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Possible side effects

It's important that you know and understand the side effects you may experience while taking SUTENT ® (sunitinib malate). Some of these side effects you and your doctor may be able to manage. Other side effects may not be manageable. If you’re having some side effects, your doctor may decide to adjust or stop your treatment. Your doctor may also decide that SUTENT is not right for you and discontinue your medication. That’s why it’s important to tell your healthcare team about ANY side effects you are experiencing.

Be sure to pay attention to all your side effects. They may be signs that let you and your doctor know what is happening in your body. Work with your healthcare team to determine when to call with questions or concerns. The sooner your team knows about your side effects, the sooner they can help you manage them.

Serious Side Effects

SUTENT may cause serious side effects. Some side effects are more serious than others. Discuss these potential side effects with your doctor. Let your doctor know if you experience any of the warning signs in this section.

Click the name of each side effect to learn more.

SUTENT can cause severe liver problems, that can lead to death.Tell your healthcare provider right away if you develop any of the following signs and symptoms of liver problems during treatment with SUTENT:

  • Itching
  • Yellow eyes or skin
  • Dark urine
  • Pain or discomfort in the right upper stomach area

Your healthcare provider should do blood tests to check your liver function before you start taking and during treatment with SUTENT. Your healthcare provider may tell you to temporarily or permanently stop taking SUTENT if you develop liver problems.

Sutent may cause heart problems, that can lead to death.

Heart problems may include heart failure, heart attack and heart muscle problems (cardiomyopathy) that can lead to death. Tell your healthcare provider if you feel very tired, are short of breath, or have swollen feet and ankles. Your healthcare provider may stop your treatment with SUTENT if you have signs and symptoms of heart failure.

Changes in the electrical activity of your heart called QT prolongation can cause irregular heartbeats that can be life threatening. Your healthcare provider may do electrocardiograms and blood tests (electrolytes) to watch for these problems during your treatment with SUTENT. Tell your healthcare provider immediately if:

  • You feel faint or lightheaded, or you pass out
  • You feel dizzy
  • You feel your heartbeat is irregular or fast

High blood pressure is common with SUTENT and may sometimes be severe. Follow your healthcare provider’s instructions about having your blood pressure checked regularly. Call your healthcare provider if your blood pressure is high, or if you have any of the following signs or symptoms of high blood pressure:

  • Severe headache
  • Lightheadedness
  • Dizziness
  • Change in vision

Your healthcare provider may prescribe medicine for you to treat high blood pressure, if needed. Your healthcare provider may temporarily stop your treatment with SUTENT until your high blood pressure is controlled.

Bleeding is common with SUTENT, but SUTENT can also cause severe bleeding problems that can lead to death. Call your healthcare provider right away if you have any of these symptoms or a serious bleeding problem during treatment with SUTENT, including:

  • Painful, swollen stomach (abdomen)
  • Vomiting blood
  • Black, sticky stools
  • Bloody urine
  • Headache or change in your mental status
  • Coughing up blood

Your healthcare provider:

  • Can tell you about other symptoms to watch for
  • May do blood tests if needed and monitor you for bleeding

Call your doctor if you have any swelling or bleeding during treatment with SUTENT.

Some people have had tears in their stomach or intestine (perforation), or have developed an abnormal opening between the stomach and intestine (fistula). Get medical help right away if you get stomach-area (abdominal) pain that does not go away or is severe during treatment with SUTENT.

TLS is caused by the fast breakdown of cancer cells and may lead to death. TLS can cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, seizure, and sometimes death. Your healthcare provider may do blood tests to check you for TLS.

Thrombotic microangiopathy (TMA) including thrombotic thrombocytopenia purpura (TTP) and hemolytic uremic syndrome (HUS). TMA is a condition that involves injury to the smallest blood vessels, and blood clots that can happen while taking SUTENT. TMA is accompanied by a decrease in red cells and cells that are involved with clotting. TMA may harm your body’s organs such as the brain and kidneys, and can sometimes lead to death. Your healthcare provider may tell you to stop taking SUTENT if you develop TMA.

Some people who have taken SUTENT have developed protein in their urine, and in some cases, kidney problems that can lead to death.

Your healthcare provider will check you for this problem. If there is too much protein in your urine, your healthcare provider may tell you to stop taking SUTENT.

Treatment with SUTENT has caused severe skin reactions that can lead to death, including:

  • Severe rash with blisters or peeling of the skin
  • Painful sores or ulcers on the skin, lips, or inside the mouth
  • Tissue damage (necrotizing fasciitis)

If you have any signs or symptoms of severe skin reactions, stop taking SUTENT and call your healthcare provider or get medical help right away.

Your healthcare provider may do tests to check your thyroid and adrenal gland function during SUTENT treatment. Tell your healthcare provider if you have any of the following signs and symptoms during your treatment with SUTENT:

  • Tiredness that gets worse and does not go away
  • Loss of appetite
  • Problems with heat
  • Feeling nervous or agitated, tremors
  • Sweating
  • Nausea or vomiting
  • Diarrhea
  • Fast heart rate
  • Weight gain or weight loss
  • Feeling depressed
  • Irregular menstrual periods or no menstrual periods
  • Headache
  • Hair loss

Low blood sugar can happen with SUTENT, and may cause you to become unconscious, or you may need to be hospitalized. Low blood sugar with SUTENT may be worse in patients who have diabetes and take anti-diabetic medicines. Your healthcare provider should check your blood sugar levels regularly during treatment with SUTENT and may need to adjust the dose of your anti-diabetic medicines. Signs and symptoms of low blood sugar may include:

  • Headache
  • Drowsiness
  • Weakness
  • Dizziness
  • Confusion
  • Irritability
  • Hunger
  • Fast heartbeat
  • Sweating
  • Feeling jittery

Call your healthcare provider right away if you have any signs or symptoms of severe low blood sugar during your treatment with SUTENT.

Severe jaw-bone problems have happened in some people who take SUTENT. Certain risk factors such as taking a bisphosphonate medicine or having dental disease may increase your risk of getting osteonecrosis. Your healthcare provider may tell you to see your dentist before you start taking SUTENT. Your healthcare provider may tell you to avoid dental procedures, if possible, during your treatment with SUTENT, especially if you are receiving a bisphosphonate medicine into a vein (intravenous).

Wounds may not heal properly during SUTENT treatment. Tell your healthcare provider if you have or plan to have any surgery before starting or during treatment with SUTENT.

  • Your healthcare provider may tell you to temporarily stop taking SUTENT if you are planning to have certain types of surgery
  • Your healthcare provider should tell you when you may start taking SUTENT again after surgery

SUTENT can harm your unborn baby. Tell your healthcare provider if you are pregnant or plan to become pregnant. You and your partner should use effective birth control (contraception) during and after treatment with SUTENT.

  • Females should continue to use birth control for at least 4 weeks after their last dose of SUTENT.
  • Males should continue to use birth control for at least 7 weeks after their last dose of SUTENT.
Common SUTENT side effects
Click each of these common side effects to learn more and, where tips are available, find out how to address the side effect.

You and your doctor may be able to manage some side effects. Others, however, may not be manageable. If you’re having some side effects, your doctor may decide to adjust or stop your treatment. That’s why it’s important to tell your healthcare team about ANY side effects you are experiencing.

Always talk to your doctor or nurse about any side effects you have as soon as you notice them. Do not wait until they become serious.

    While on treatment, you may feel tired or weak. Fatigue is common during treatment for cancer. But it may also be a sign of a more serious medical problem. Call your doctor or nurse for a full evaluation if you feel tired or weak while on your treatment.

  • Take short naps or breaks
  • Eat well and drink plenty of fluids
  • Take short walks or do light exercise if you feel up to it
  • Try to maintain normal work and social schedules

You and your doctor may be able to manage some side effects. Others, however, may not be manageable. If you’re having some side effects, your doctor may decide to adjust or stop your treatment. That’s why it’s important to tell your healthcare team about ANY side effects you are experiencing.

Always talk to your doctor or nurse about any side effects you have as soon as you notice them. Do not wait until they become serious.

Diarrhea is defined as 3 or more loose or watery stools/bowel movements in one day. If you have these symptoms, call your doctor or nurse. It is important for you and your doctor to try to manage diarrhea as soon as it begins.

Once the diarrhea resolves:

  • Ask your doctor or nurse if you can be treated with over-the-counter medications
  • Try yogurt containing probiotics
  • Eat foods containing fiber–especially soluble fiber which can be found in oatmeal, nuts, beans, and apples
  • Eat small but frequent meals
  • Avoid spicy foods, fatty foods, caffeine, and fruit
  • Drink lots of fluids, but in small amounts

You and your doctor may be able to manage some side effects. Others, however, may not be manageable. If you’re having some side effects, your doctor may decide to adjust or stop your treatment. That’s why it’s important to tell your healthcare team about ANY side effects you are experiencing.

Always talk to your doctor or nurse about any side effects you have as soon as you notice them. Do not wait until they become serious.

If you develop mouth pain, tell your doctor immediately. He or she may tell you to stop your treatment.

    Here are a few tips that can help you manage pain, swelling, or sores inside your mouth:

  • Avoid hot, spicy, or acidic foods
  • Eat foods that are soft
  • Use a straw for drinking liquids
  • Use an alcohol-free mouthwash, and rinse your mouth often with water
  • Avoid toothpastes with whiteners (ie, peroxide) and use a soft toothbrush
  • Ask your doctor if there are over-the-counter or prescription medications that may help you manage your health condition

You and your doctor may be able to manage some side effects. Others, however, may not be manageable. If you’re having some side effects, your doctor may decide to adjust or stop your treatment. That’s why it’s important to tell your healthcare team about ANY side effects you are experiencing.

Always talk to your doctor or nurse about any side effects you have as soon as you notice them. Do not wait until they become serious.

    Nausea is defined as feeling as if you are about to throw up. It is best to call your doctor or nurse at the first sign of nausea or vomiting. This is especially important if these symptoms keep you from taking your oral medications. Your doctor may prescribe a medicine for these symptoms.

  • Eat small meals
  • Avoid foods that are sweet, fried, or fatty
  • Drink lots of fluids, but in small amounts
  • If you vomit, start with small amounts of water, broth, or other clear liquids when you are ready to eat again
    • If that stays down, then try soft foods. Some examples include gelatin, yogurt, strained soup, or cream of wheat. Slowly work up to eating solid food. Make sure that you do not eat any food that you are allergic to

You and your doctor may be able to manage some side effects. Others, however, may not be manageable. If you’re having some side effects, your doctor may decide to adjust or stop your treatment. That’s why it’s important to tell your healthcare team about ANY side effects you are experiencing.

Always talk to your doctor or nurse about any side effects you have as soon as you notice them. Do not wait until they become serious.

While on treatment, you may have less desire to eat. But maintaining good nutrition and a healthy weight are important to your treatment. Protein and calories are even more vital to someone with cancer.

  • Eat several small meals a day—5 or 6 isn't out of the question
  • Eat when you are hungry
  • Enjoy snacks and try to make them nutritious. Find calories and protein in dried fruits, nuts, cheeses, and even milkshakes
  • Add gravy, butter, or cheese to your favorite foods for added protein and calories
  • Drink fluids between meals rather than filling up with them during meals
  • If you are too tired to cook, ask a friend or family member to make you something. You may be surprised how many people you have to help
  • If the smell of a certain food is bothering you, it may help to eat it cold or at room temperature
  • If you're having trouble tasting your favorite foods, try adding herbs or condiments
  • A registered dietitian (RD) may have more ideas to offer you

While on treatment, you may experience indigestion, also known as dyspepsia. Here are a few simple tips that can help you manage indigestion:

  • Avoid talking while you chew, or eating too fast
  • Drink beverages after rather than during meals
  • Avoid late-night eating
  • Try to relax after meals
  • Avoid spicy foods
  • Avoid alcohol
  • If you smoke, quit

You and your doctor may be able to manage some side effects. Others, however, may not be manageable. If you’re having some side effects, your doctor may decide to adjust or stop your treatment. That’s why it’s important to tell your healthcare team about ANY side effects you are experiencing.

Always talk to your doctor or nurse about any side effects you have as soon as you notice them. Do not wait until they become serious.

While on treatment, you may experience an upset stomach. Upset stomach is common for patients who are being treated for cancer. Call your doctor or nurse if you have an upset stomach.

  • Avoid heavy meals, coffee, and alcohol
  • Sleep in a more upright position, propped up on a pillow
  • Ask your doctor if there are over-the-counter or prescription medications that may help you manage your condition

Some patients may have blisters or a rash on the palms of their hands or soles of their feet. This is called hand-foot syndrome. Tell your doctor or nurse if you start to develop skin problems. He or she may give you specific treatments, which may include lotions, moisturizers, or pain medicines. You can also try some of the following:

  • Wear loose cotton clothes
  • Use sunscreen
  • Clean hands and feet with lukewarm water and gently pat dry
  • Apply creams containing lanolin or urea to the hands and feet liberally and often
  • Avoid tight-fitting shoes and jewelry or rubbing pressure on the hands and feet

High blood pressure is common with SUTENT and may sometimes be severe. Follow your healthcare provider's instructions about having your blood pressure checked regularly. Call your healthcare provider if your blood pressure is high or if you have any of the following signs or symptoms of high blood pressure:

  • severe headache
  • lightheadedness
  • dizziness
  • change in vision

Your healthcare provider may prescribe medicine for you to treat high blood pressure, if needed. Your healthcare provider may temporarily stop your treatment with SUTENT until your high blood pressure is controlled.

If you have high blood pressure, here are some healthy lifestyle choices that may be able to help – but check with your healthcare provider first:

  • Get regular exercise
  • Keep your weight under control
  • Lower your alcohol intake or avoid alcohol altogether
  • Lower the amount of sodium you eat in your food

You and your doctor may be able to manage some side effects. Others, however, may not be manageable. If you’re having some side effects, your doctor may decide to adjust or stop your treatment. That’s why it’s important to tell your healthcare team about ANY side effects you are experiencing.

Always talk to your doctor or nurse about any side effects you have as soon as you notice them. Do not wait until they become serious.

While on treatment, foods you usually enjoy may taste bland, different, or bad. Call your doctor or nurse if you experience taste changes.

  • Try cold or frozen foods as they may taste better than hot foods
  • Flavor your food with herbs, seasonings, sugar, or sauces
  • Keep a clean and healthy mouth by brushing and flossing often

While on treatment, you may experience low platelet counts. Platelets play a role in preventing bleeding and repairing damaged blood vessels. Low platelet counts can be detected through a blood test.

Bleeding is common with SUTENT, but SUTENT can also cause severe bleeding problems that can lead to death. Call your healthcare provider right away if you have any of these symptoms or a serious bleeding problem during treatment with SUTENT, including:

  • painful, swollen stomach (abdomen)
  • vomiting blood
  • black, sticky stools
  • bloody urine
  • headache or change in your mental status
  • coughing up blood

To help manage your bleeding, your doctor may prescribe:

  • Vitamin K injections
  • Clotting agents
  • Blood plasma or platelet transfusions
  • Medication for platelet problems

Here are a few tips to help you avoid bleeding:

  • Ask your doctor before drinking alcohol or taking new medications. These can make bleeding problems worse
  • Use an extra soft toothbrush, and don't floss if your gums bleed
  • Blow your nose gently using a soft tissue
  • Be careful using scissors, knives, needles, or other sharp tools
  • Take steps to prevent burns while cooking
  • Shave with an electric razor
  • Avoid contact sports and other activities that might cause injury

Skin conditions as a result of your treatment do not usually pose health risks. However, a rash, dry, thick, callusing, cracking, widespread blistering, or peeling or damage of the skin may be a sign of a more serious side effect. Call your doctor right away if you experience these symptoms. Treatment with SUTENT may also cause changes in skin or hair color.

Because your medicine inside the capsule is yellow, it may make your skin and hair look yellow or get lighter in color. While this side effect usually poses no health risks, yellow skin can be a sign of a more serious side effect. If you develop yellow skin, please call your doctor right away.

Here are a few tips that can help you manage skin or hair changes:

  • Maintain a balanced diet, while cutting down on salt
  • Walk and exercise. This can help increase circulation and reduce swelling
  • Wear compression socks or elastic sleeves. This can help with your circulation and reduce swelling
  • Elevate your arms or legs when sitting or lying
  • Wear thick cotton gloves and/or socks in order to protect your skin
  • Avoid tight footwear and excessive friction
  • Avoid hot water when washing hands, bathing, or showering
  • Take natural diuretics such as green, leafy vegetables (especially if you are taking enemas)
  • Your doctor may prescribe diuretics
  • Your doctor or nurse may give you specific treatments, which may include lotions, moisturizers, or pain medicines
  • Discuss this side effect with your doctor or nurse so he or she can perform a full evaluation